Design History File (DHF)

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Design History File (DHF) is a compilation of records that describes the design history of a finished device.

The Design History File (DHF) is a core requirement under the U.S. FDA’s Quality System Regulation (QSR) for medical device manufacturers, specifically detailed in 21 CFR 820.30(j).

Purpose of the DHF

Mandate: Each manufacturer must establish and maintain a DHF for each type of device.

Purpose: The DHF serves to contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part (i.e., 21 CFR Part 820). It is the documented evidence that the rigorous Design Controls process was followed.

Key Contents and Requirements

The DHF must either physically contain or clearly reference all records generated throughout the design and development lifecycle, ensuring traceability and compliance with the established procedures.

Required documentation to be included in or referenced by the DHF includes the results of the key design control phases:

Design Control Element

Required DHF Documentation

Source

Design Planning (820.30(b))

Records demonstrating the design plan was reviewed, updated, and approved as development evolved.

Design Review (820.30(e))

The results of a design review, including the identification of the design, the date, and the individual(s) performing the review, shall be documented in the DHF.

Design Verification (820.30(f))

The results of the design verification (confirming output meets input), including identification of the design, method(s), date, and the individual(s) performing the verification, shall be documented in the DHF.

Design Validation (820.30(g))

The results of the design validation (confirming conformance to user needs and intended use(s)), including identification of the design, method(s), date, and the individual(s) performing the validation, shall be documented in the DHF.

Design Changes (820.30(i))

Documentation related to the identification, documentation, review, and approval of design changes.

Special Documentation Requirements

The DHF also serves as the formal location for documenting regulatory decisions related to the device design:

• UDI Exception: If a labeler decides to use an exception to the requirement that a device must be directly marked with a Unique Device Identifier (UDI), the basis of that decision must be documented in the design history file.

Distinction from Related Records

While the DHF focuses on the design history, other required quality records focus on the production and specifications of the device:

• Device Master Record (DMR): The finished design output is the basis for the Device Master Record. The DMR is a compilation of records that contains the procedures and specifications for a finished device, detailing how to manufacture it (e.g., specifications, production processes, quality assurance procedures, labeling specifications, etc.).
• Device History Record (DHR): The DHR compiles the production history of a finished device. The DHR is maintained for each batch, lot, or unit to demonstrate that the device was manufactured in accordance with the DMR and QSR requirements.
• Quality System Record (QSR): This record includes procedures and documentation of activities that are not specific to a particular type of device, such as management reviews.

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